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临床试验/NCT07108946
NCT07108946Enrolling By Invitation不适用

Influence of Skin Tone and Background Color on the Accuracy of Auricular Scanning: A Clinical Trial

yasmine Elsherbeeny2 个研究点 分布在 1 个国家目标入组 135 人开始时间: 2025年7月26日最近更新:

试验速览

阶段
不适用
状态
Enrolling By Invitation
发起方
入组人数
135
试验地点
2
主要终点
Evaluation of the effect of different backgrounds and skin tones on trueness of auricular scans via intraoral scanner.

研究概览

简要总结

The goal of this study is to find the best miss and match background color around an ear when taking scans for it , the investigators will recruit participants of three different skin tone and will scan their ear three times; one scan without any background, second scan with black one and the third scan with white background, then the investigators will take an actual physical impression of the participants ear and the investigators will obtain a cast which will be scanned also and its scan will be compared to the three scans taken with different backgrounds to find the best combination.

详细描述

Manufacturing the Extraoral prosthesis is troublesome for the patient, the dental practitioner and the dental technician. When a person misses his ear congenitally or due to trauma, he wishes to have an accurate replacement for his ear with minimum steps and effort. Digital technology has been providing the dental field with the most helpful equipment in such cases. Owing to the innovation of intraoral scanners with its continuous refinement, this patient now can rest assured that he will have his auricular prosthesis with less number of visits and less effort. There are different environmental factors that can affect scanning accuracy such as patients skin tone and scanning background.This study aims to evaluate the different backgrounds and skin tones effect on the trueness of auricular scanning. Participants with different skin tones (black, white and intermediate) will be selected with intact ears, then conventional impression will be taken and stone cast will be obtained and scanned via an extraoral scanner, then intraoral scanner will be used to scan the auricle three times, first with a black background, second with white background, third without background. Trueness of the scans will be evaluated by metrological software. Data will be collected, tabulated, and statistically analyzed.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Crossover
主要目的
Other
盲法
None

入排标准

性别
All
接受健康志愿者

入选标准

  • Three types of skin tones will be selected; type I, type III and type VI according to The Fitzpatrick Scale.
  • Participants with intact ears.
  • Participants not exposed to sun burns or tans.

排除标准

  • 1- Uncooperative participants.
  • 2-Participants without intact ears.

结局指标

主要结局

Evaluation of the effect of different backgrounds and skin tones on trueness of auricular scans via intraoral scanner.

时间窗: The study is expected to take place over a 6-week period. Each participant will be scheduled for one session lasting approximately one hour.

The resultant standard tessellation files (STL) of every scan done via the intraoral scanner will be compared to the STL of the scan done via the extraoral scanner of the same participant by a metrological software to evaluate trueness.

次要结局

未报告次要终点

研究者

发起方
yasmine Elsherbeeny
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

yasmine Elsherbeeny

lecturer of prosthodontics, faculty of dentistry, ain shams university

Ain Shams University

研究点 (2)

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